ARCHITECT HBsAg Next Confirmatory Assay - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Disponible depuis:

Abbott Australasia Pty Ltd Diagnostic Division

classe:

Class 4

Fabriqué par:

Abbott Ireland Diagnostics Division Finisklin Business Park, SLIGO Ireland

Domaine thérapeutique:

48321 - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

indications thérapeutiques:

This assay consists of two single tests (HBsAgNx C1, also referred to as C1 and HBsAgNx C2, also referred to as C2) that are both one-step pre-treatment immunoassays for the confirmation of the presence of hepatitis B surface antigen (HBsAg) in human serum and plasma using chemiluminescent microparticle immunoassays (CMIA) technology with flexible assay protocols, referred to as Chemiflex. The HBsAg Next Confirmatory assay is a chemiluminescent microparticle immunoassay (CMIA) for the confirmation of the presence of hepatitis B surface antigen (HBsAg) in human serum and plasma including specimens collected post mortem (nonheart- beating) up to 24 hours after death by means of specific antibody neutralization on the ARCHITECT iSystem. It is intended to be used for the confirmation of samples found to be repeatedly reactive by HBsAg Next Qualitative.

Statut de autorisation:

A

Date de l'autorisation:

2020-05-18